Unichem Topiramate Tablets 50mg Recall: Discoloration Hazard
Unichem Pharmaceuticals USA recalls 50mg Topiramate tablets due to discoloration. This may affect safety but does not indicate immediate risk. Check NDC 29300-116-05 for affected lots.
Lower-risk recall
Discoloration
Contact the company
What happened, in plain English
Unichem Pharmaceuticals USA recalled 50mg Topiramate tablets that may have discoloration. This issue could affect safety but does not indicate immediate risk to users. Read more at govinfonow.com/recall/35636-unichem-topiramate-tablets-50mg-recall-discoloration-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/35636-unichem-topiramate-tablets-50mg-recall-discoloration-hazard · Updated October 4, 2026 · FDA enforcement record: FDA #D-0255-2022
Cite this page
“Unichem Topiramate Tablets 50mg Recall: Discoloration Hazard.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/35636-unichem-topiramate-tablets-50mg-recall-discoloration-hazard. Based on FDA recall #D-0255-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0255-2022%22&limit=1).
Why it’s dangerous
Discoloration in the tablets could indicate instability or impurities that might affect the medication's effectiveness. However, the recall does not specify a risk of harm to users.
Who’s affected
Prescription users of Topiramate 50mg tablets in 500-count bottles. Those with specific medical conditions requiring precise dosing may be at slightly higher risk.
How to tell if you have this one
Check for NDC 29300-116-05 on the bottle. The product was manufactured by Unichem Laboratories LTD in Meerut, India, and sold in the US under Unichem Pharmaceuticals USA Inc.
- Brand
Unichem Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 29300-116-05 on the bottle label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0255-2022 (October 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0255-2022 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.